LED Eye mask (EY-20R, A20, EY-20N)
K-Number: K233556 · 2024-01-04
Decision Date2024-01-04
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LED Eye mask (EY-20R, A20, EY-20N) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-01-04 under approval number K233556. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LED Eye mask (EY-20R, A20, EY-20N)?
LED Eye mask (EY-20R, A20, EY-20N) is a medical device that received FDA 510(k) clearance on 2024-01-04. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K233556.
When was LED Eye mask (EY-20R, A20, EY-20N) approved by the FDA?
LED Eye mask (EY-20R, A20, EY-20N) received FDA 510(k) clearance on 2024-01-04, under approval number K233556.
What company makes LED Eye mask (EY-20R, A20, EY-20N)?
LED Eye mask (EY-20R, A20, EY-20N) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..
What is the FDA product code for LED Eye mask (EY-20R, A20, EY-20N)?
The FDA product code for LED Eye mask (EY-20R, A20, EY-20N) is OHS.
Other Devices by Shenzhen Kaiyan Medical Equipment Co., Ltd.
Related Devices (Code: OHS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.